Pre-pectoral Breast Reconstruction With or Without Mesh

Tianjin Medical University Cancer Institute and Hospital164 enrolled

Overview

To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Prepectoral Breast Reconstruction TiLOOP Mesh

Interventions

prepectoral breast reconstructionPROCEDURE

Patients receive immediate prepectoral breast reconstruction

Tiloop Mesh implantationPROCEDURE

Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction; 2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy; 3. Tissue expander size =\<800cc, implant size =\<600cc; 4. The blood perfusion of breast skin flap was well; 5. Do not smoking in the last 4 weeks or more 6. Patients with normal expectations and mental health for breast reconstruction; 7. Signed consent to participate Exclusion Criteria: 1. Poor perfusion of breast mastectomy flap; 2. II stage breast reconstruction patients; 3. History of chest radiotherapy; 4. BMI greater than 35; 5. Patients who have not quit smoking within the last 4 weeks;

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING